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Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

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Conditions

Hereditary AngioedemaHereditary Angioedema Type IHereditary Angioedema Type IIHereditary Angioedema Types I and IIHereditary Angioedema AttackHereditary Angioedema With C1 Esterase Inhibitor DeficiencyHereditary Angioedema - Type 1Hereditary Angioedema - Type 2C1 Esterase Inhibitor [C1-INH] DeficiencyC1 Esterase Inhibitor DeficiencyC1 Esterase Inhibitor, Deficiency ofC1 Inhibitor DeficiencyHereditary Angioedema - Type 3Hereditary Angioedema Type IIIHAEHAE Type IHAE Type IIOral TreatmentBradykinin B2 Receptor AntagonistsPHVS416PHA121On-DemandDeucrictibantPharvarisHAE Type III

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, 2-period, 2-treatment cross-over study to evaluate the efficacy and safety of orally administered deucrictibant compared to placebo for the on-demand treatment of HAE attacks, including non-severe laryngeal attacks, in participants ≥12 to ≤75 years of age with HAE type 1, type 2, or type 3, a proportion of whom are using long-term prophylactic medication for HAE.

Official Title

A Phase 3, Randomized, Double-blind, Placebo-controlled, Cross-over Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Attacks in Adolescents and Adults With Hereditary Angioedema

Quick Facts

Study Start:2024-02-26
Study Completion:2025-10-17
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06343779

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of written informed consent/assent.
  2. 2. Male or female, aged ≥12 to ≤75 years at the time of providing written informed consent/assent.
  3. 3. Diagnosis of HAE-1/2/3.
  4. 4. History of at least 2 HAE attacks in the last 3 months before screening.
  5. 5. Experience with using standard-of-care treatment to effectively manage on-demand treatment for HAE attacks.
  6. 6. Participants on long-term prophylactic therapy with plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat, or lanadelumab) must be on a stable dose and regimen and intend to remain on the same dose for 6 months before screening and the duration of the study. OR, Participant has stopped using plasma-derived C1-INH (danazol, anti-fibrinolytics, berotralstat) at least 2 weeks or lanadelumab at least 10 weeks before screening.
  7. 7. Capable of recording, without assistance, electronic HAE diary and ePRO data using an electronic device.
  8. 8. For adolescent participants aged ≥12 and \<18 years of age: body weight ≥40 kg.
  9. 9. Female participants of childbearing potential must agree to the protocol specified pregnancy testing and contraception methods.
  1. 1. Any female who is pregnant, plans to become pregnant, or is breastfeeding.
  2. 2. Any diagnosis of angioedema other than HAE.
  3. 3. Any clinically significant comorbidity or systemic dysfunction that would interfere with the participant's safety or ability to participate in the study.
  4. 4. Use of attenuated androgens for short-term prophylaxis within 2 weeks before screening.
  5. 5. Abnormal hepatic function.
  6. 6. Abnormal renal function (eGFR \<60 ml/min/1.73 m2).
  7. 7. History of alcohol or drug abuse within the previous year, or current evidence of substance dependence or abuse.
  8. 8. Has received prior on-demand HAE treatment with deucrictibant.
  9. 9. Currently participating in any other investigational drug study or receiving other investigational treatment within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
  10. 10. Prior gene therapy for any indication at any time.
  11. 11. Use of concomitant medications with systemic absorption that are strong inhibitors of CYP3A4 or strong inducers of CYP3A4 within the last 30 days, or within 5 half-lives (whichever is longer) of the time of randomization.
  12. 12. Known hypersensitivity to study drug or any of the excipients of study drug.

Contacts and Locations

Principal Investigator

Study Director, Pharvaris
STUDY_DIRECTOR
Pharvaris Netherlands B.V.

Study Locations (Sites)

Study Site
Birmingham, Alabama, 35209
United States
Study Site
Paradise Valley, Arizona, 85258
United States
Study Site
Little Rock, Arkansas, 72205
United States
Study Site
San Diego, California, 92122
United States
Study Site
Santa Monica, California, 90404
United States
Study Site
Walnut Creek, California, 94598
United States
Study Site
Colorado Springs, Colorado, 80907-6231
United States
Study Site
Chevy Chase, Maryland, 20815
United States
Study Site
Boston, Massachusetts, 02115
United States
Study Site
Detroit, Michigan, 48202
United States
Study Site
St Louis, Missouri, 63141
United States
Study Site
Hershey, Pennsylvania, 17033
United States
Study Site
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: Pharvaris Netherlands B.V.

  • Study Director, Pharvaris, STUDY_DIRECTOR, Pharvaris Netherlands B.V.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-26
Study Completion Date2025-10-17

Study Record Updates

Study Start Date2024-02-26
Study Completion Date2025-10-17

Terms related to this study

Keywords Provided by Researchers

  • HAE
  • HAE Type I
  • HAE Type II
  • Oral Treatment
  • Bradykinin B2 Receptor Antagonists
  • PHVS416
  • PHA121
  • On-Demand
  • Deucrictibant
  • Pharvaris
  • HAE Type III

Additional Relevant MeSH Terms

  • Hereditary Angioedema
  • Hereditary Angioedema Type I
  • Hereditary Angioedema Type II
  • Hereditary Angioedema Types I and II
  • Hereditary Angioedema Attack
  • Hereditary Angioedema With C1 Esterase Inhibitor Deficiency
  • Hereditary Angioedema - Type 1
  • Hereditary Angioedema - Type 2
  • C1 Esterase Inhibitor [C1-INH] Deficiency
  • C1 Esterase Inhibitor Deficiency
  • C1 Esterase Inhibitor, Deficiency of
  • C1 Inhibitor Deficiency
  • Hereditary Angioedema - Type 3
  • Hereditary Angioedema Type III